Cleared Traditional

K954095 - MEDICOOL (MODIFICATON)

K954095 is an FDA 510(k) clearance for MEDICOOL (MODIFICATON), manufactured by Microclimate Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K954095 · Microclimate Systems, Inc. · Physical Medicine device
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Mar 1996
Decision
199d
Days
Class 2
Risk

K954095 is an FDA 510(k) clearance for the MEDICOOL (MODIFICATON). Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Microclimate Systems, Inc. (Sanford, US). The FDA issued a Cleared decision on March 6, 1996 after a review of 199 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Microclimate Systems, Inc. devices

FDA 510(k) Submission Details - K954095

510(k) Number K954095 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 20, 1995
Decision Date March 06, 1996
Days to Decision 199 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 115d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 41
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K954095.
CRYTRON SYSTEM
K955529 · Mark H. Friedman · Jun 1996
SPORTS CONTRAST THERAPY SYSTEM ST 7000
K955326 · Burke Neutech, Inc. · Apr 1996
MODEL 1100 COLD THERAPY DEVICE
K955057 · Smith and Nephew Donjoy, Inc. · Mar 1996
EBICE
K953532 · Electro-Biology, Inc. · Oct 1995
THERMOCOOL SYSTEM
K950395 · Zimmer, Inc. · Aug 1995
BABYTHERM 8000 WB
K945467 · Drager, Inc. · Apr 1995